Foot Ulcer, DiabeticPhase 2NCT00516958
Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
A Phase 2 study testing Topical Dermacyn, Topical Dermacyn and Levofloxacin and Topical Saline and Levofloxacin in people with Foot Ulcer, Diabetic, run by Oculus Innovative Sciences, Inc. at 16 sites in United States.
Trial summary
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Topical Dermacyn, Topical Dermacyn and Levofloxacin and Topical Saline and Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must meet all of the following inclusion criteria to be enrolled in the study:
- Males and females > 18 years of age with diabetes mellitus (type 1 or type 2, controlled).
- Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B.
- Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy.
- Foot ulcers located in the plantar, dorsal or malleolar areas.
- Ulcers 1- 9 cm2 in size.
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- An accessible infection site for culture.
- ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg.
- Palpable pulse on the study foot (either dorsalis or posterior tibial artery).
- Willing and able to give informed consent.
- Willing to comply with the requirements for participation in the study.
Who cannot join
- Patients are excluded if they meet any of the following criteria at the time of randomization:
- Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
- Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
- Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
- The patient´s ulcer is located on the stump of an amputated extremity.
- The patient's ulcer is due to a non-diabetic etiology.
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- Infections complicated by the presence of prosthetic materials.
- Osteomyelitis
- Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding.
- Known to have liver disease, with total bilirubin > 5 times the Upper Limit of Normal (ULN); known to have neutropenia (absolute neutrophil count <500 cells/mm3).
- Hypersensitivity to chlorine or quinolones.
- Need for any additional concomitant systemic antibacterial agent other than the study drug(s).
- Concomitant glucocorticoid doses (> 5mg prednisone a day or equivalent).
- Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders.
- A history of diseases of immune function (HIV, chronic granulomatous disease).
- Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day.
- Has received an investigational agent ≤1 month prior to the baseline evaluation.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Boca Raton, Florida, 33486
Study site
Boston, Massachusetts, 02215
Study site
Denver, Colorado, 80220
Study site
Evansville, Indiana, 47714
Study site
Harrisburgh, Pennsylvania, 17112
Study site
Hazleton, Pennsylvania, 18201
Study site
La Jolla, California, 92037
Study site
Los Angeles, California, 90063-2326
Study site
Louisville, Kentucky, 40222
Study site
New Haven, Connecticut, 06515
Study site
Pittsburgh, Pennsylvania, 15224
Study site
Salt Lake City, Utah, 54102
Study site
San Diego, California, 92103-8896
Study site
Santa Rosa, California, 34669
Study site
Spring Hill, Florida, 34609
Study site
Tucson, Arizona, 85710
About this study
Official title: An Open Label, Three Arm, Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care vs. Oral Levofloxacin vs. Combined Therapy for Mild Diabetic Foot Infections
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Topical Dermacyn, Topical Dermacyn and Levofloxacin, Topical Saline and Levofloxacin
- Keywords
- diabetic, ulcer, infection, topical, wound
- Medical subject headings
- Diabetic Foot, Ulcer, Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical DermacynDrug
Also called Dermacyn™ Wound Care
Topical Dermacyn once a day for 10 Days
Topical Dermacyn and LevofloxacinDrug
Also called Dermacyn™ Wound Care, Levaquin®
Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
Topical Saline and LevofloxacinDrug
Also called Saline Solution, Levoquin®
Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Topical Dermacyn Receives: Drug: Topical Dermacyn |
| 2 | Active comparator | Topical Dermacyn and levofloxacin Receives: Drug: Topical Dermacyn and Levofloxacin |
| 3 | Active comparator | Topical saline and levofloxacin Receives: Drug: Topical Saline and Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers
Measured: Visit 3 (Day 10); Visit 4 (Day 24)
Secondary outcomes (1)
To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes
Measured: Visit 2 (Day 3); Visit 3 (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oculus Innovative Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andres Gutierrez, M.D., Ph.D., Study director, Oculus Innovative Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516958
- Sponsor's protocol ID
- OIS-005
- Status last verified
- Jan 2008
- First submitted
- 14 Aug 2007
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Goretti C, Mazzurco S, Nobili LA, Macchiarini S, Tedeschi A, Palumbo F, Scatena A, Rizzo L, Piaggesi A. Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication. Int J Low Extrem Wounds. 2007 Mar;6(1):22-7. doi: 10.1177/1534734606298543.
PubMed 17344198Landa-Solis C, Gonzalez-Espinosa D, Guzman-Soriano B, Snyder M, Reyes-Teran G, Torres K, Gutierrez AA. Microcyn: a novel super-oxidized water with neutral pH and disinfectant activity. J Hosp Infect. 2005 Dec;61(4):291-9. doi: 10.1016/j.jhin.2005.04.021. Epub 2005 Oct 19.
PubMed 16242210Duc Ql, Breetveld M, Middelkoop E, Scheper RJ, Ulrich MM, Gibbs S. A cytotoxic analysis of antiseptic medication on skin substitutes and autograft. Br J Dermatol. 2007 Jul;157(1):33-40. doi: 10.1111/j.1365-2133.2007.07990.x. Epub 2007 Jun 6.
PubMed 17553033Medina-Tamayo J, Sanchez-Miranda E, Balleza-Tapia H, Ambriz X, Cid ME, Gonzalez-Espinosa D, Gutierrez AA, Gonzalez-Espinosa C. Super-oxidized solution inhibits IgE-antigen-induced degranulation and cytokine release in mast cells. Int Immunopharmacol. 2007 Aug;7(8):1013-24. doi: 10.1016/j.intimp.2007.03.005. Epub 2007 Apr 16.
PubMed 17570318Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech.
PubMed 16771079
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Three Arm, Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care vs. Oral Levofloxacin vs. Combined Therapy for Mild Diabetic Foot Infections
- ClinicalTrials.gov ID
- NCT00516958
- Acronym / sponsor ID
- OIS-005
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- diabetic, ulcer, infection, topical, wound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Oculus Innovative Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Topical DermacynTopical Dermacyn |
| 2 | Active comparator | Drug: Topical Dermacyn and LevofloxacinTopical Dermacyn and levofloxacin |
| 3 | Active comparator | Drug: Topical Saline and LevofloxacinTopical saline and levofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A patient must meet all of the following inclusion criteria to be enrolled in the study:
Key exclusion criteria (17 listed)
- Patients are excluded if they meet any of the following criteria at the time of randomization:
- Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
- Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
- Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
- The patient´s ulcer is located on the stump of an amputated extremity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical DermacynAlso: Dermacyn™ Wound CareTopical Dermacyn once a day for 10 Days | Drug | 1 |
| Topical Dermacyn and LevofloxacinAlso: Dermacyn™ Wound Care, Levaquin®Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days | Drug | 2 |
| Topical Saline and LevofloxacinAlso: Saline Solution, Levoquin®Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days | Drug | 3 |
Primary outcome
To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers
Time frame: Visit 3 (Day 10); Visit 4 (Day 24)
1 secondary outcome
To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes
Time frame: Visit 2 (Day 3); Visit 3 (Day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2008.
- Background: PubMed 17344198Goretti C, Mazzurco S, Nobili LA, Macchiarini S, Tedeschi A, Palumbo F, Scatena A, Rizzo L, Piaggesi A. Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication. Int J Low Extrem Wounds. 2007 Mar;6(1):22-7. doi: 10.1177/1534734606298543.
- Background: PubMed 16242210Landa-Solis C, Gonzalez-Espinosa D, Guzman-Soriano B, Snyder M, Reyes-Teran G, Torres K, Gutierrez AA. Microcyn: a novel super-oxidized water with neutral pH and disinfectant activity. J Hosp Infect. 2005 Dec;61(4):291-9. doi: 10.1016/j.jhin.2005.04.021. Epub 2005 Oct 19.
- Background: PubMed 17553033Duc Ql, Breetveld M, Middelkoop E, Scheper RJ, Ulrich MM, Gibbs S. A cytotoxic analysis of antiseptic medication on skin substitutes and autograft. Br J Dermatol. 2007 Jul;157(1):33-40. doi: 10.1111/j.1365-2133.2007.07990.x. Epub 2007 Jun 6.
- Background: PubMed 17570318Medina-Tamayo J, Sanchez-Miranda E, Balleza-Tapia H, Ambriz X, Cid ME, Gonzalez-Espinosa D, Gutierrez AA, Gonzalez-Espinosa C. Super-oxidized solution inhibits IgE-antigen-induced degranulation and cytokine release in mast cells. Int Immunopharmacol. 2007 Aug;7(8):1013-24. doi: 10.1016/j.intimp.2007.03.005. Epub 2007 Apr 16.
- Background: PubMed 16771079Zahumensky E. [Infections and diabetic foot syndrome in field practice]. Vnitr Lek. 2006 May;52(5):411-6. Czech.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Gutierrez, M.D., Ph.D. study director
Oculus Innovative Sciences
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Dermacyn, Topical Dermacyn and Levofloxacin and Topical Saline and Levofloxacin in people with Foot Ulcer, Diabetic, run by Oculus Innovative Sciences, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers (time frame: Visit 3 (Day 10); Visit 4 (Day 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516958, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2008.